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临床试验/NCT06610435
NCT06610435已完成不适用

Effects of Manual Therapy and Home Exercise Treatment on Pain, Stress, Sleep and Life Quality in Patients with Bruxism: a Randomized Clinical Trial

Ankara University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Pain Level

研究概览

简要总结

Objectives: This trial aimed to examine the effects of manual therapy and home exercise treatments on pain, sleep quality, stress level and quality of life in patients with bruxism.

Methods: Thirty bruxists over the age of 18 were included in the study. The patients were randomly divided into Manual Therapy Group (MTG) and Home Exercise Group (HEG). Before treatment (T1) demographic information was obtained from all patients, they were asked to fill out the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Fonseca Anamnestic Index (FAI) and Quality of Life Scale/Short Form-36 (SF-36) and number of trigger points and pain levels were determined at baseline. Manual therapy and home exercises were applied to both groups for 8 weeks and all tests were repeated and re-evaluated at the end of 8 weeks (T2). After that, the data was analyzed with statistical tests.

详细描述

Bruxism is a common parafunctional habit defined as clenching and/or grinding of teeth occurring during sleep and/or wakefulness. Although the etiology is not known exactly, there is a consensus that it is multifactorial. Emotional stress is one of the important factors leading to bruxism. It has been shown that a stressful life has an important effect in explaining clenching during the day. In addition to stress, previous studies showing that psychiatric disorders, especially depression and anxiety disorders, accompany TMD and bruxism.

This trial aimed to examine the effects of manual therapy and home exercise treatments on pain, sleep quality, stress level and quality of life in patients with bruxism. In the study thirty bruxists over the age of 18 were included in the research protocol. The patients were randomly divided into Manual Therapy Group (MTG) and Home Exercise Group (HEG). Before treatment (T1) demographic information was obtained from all patients, they were asked to fill out the Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS), Fonseca Anamnestic Index (FAI) and Quality of Life Scale/Short Form-36 (SF-36) and number of trigger points and pain levels were determined at baseline. Manual therapy and home exercises were applied to both groups for 8 weeks and all tests were repeated and re-evaluated at the end of 8 weeks (T2). The normal distribution of the groups was tested with Kolmogorov-Smirnov. Paired Samples t test was used for intra-group comparisons at T1 and T2, and Independent t test was used for inter-group comparisons. The statistical significance level was accepted as p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

To ensure blinding, baseline and final outcome measurements were performed by researchers other than the physiotherapist performing manual therapy.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Volunteer students aged between 18-25
  • Answered "yes" to at least two of the six questions in the Bruxism questionnaire.
  • Is there anyone hear you grinding your teeth at night? Do you feel fatigue or pain in your jaw when you wake up in the morning? Do you feel pain in your teeth and gums when you wake up in the morning? Do you have a headache when you wake up in the morning? Do you notice that you grind your teeth during the day? Do you notice that you clench your teeth during the day?
  • Having at least two clinical signs of bruxism Abnormal tooth wear on the occlusal surfaces of the teeth Abfraction Gingival recession and/or cervical defect Tongue indentations or damage to the inside of the cheek Tense facial and jaw muscles, muscle sensitivity, and masseteric hypertrophy upon bidigital palpation

排除标准

  • Characterized by a neurological disease,
  • Botulinum toxin injections into the masticatory muscles in the last year,
  • Using antidepressant-type medications that will affect the central nervous system,
  • Receiving occlusal splint treatment,
  • Having more than two molar teeth missing in the posterior

结局指标

主要结局

Pain Level

时间窗: From baseline to the end of treatment at 8 weeks

Visual analog scale (VAS) was used to assess the severity of pain related to bruxism. On a 10 cm long horizontal line, "0 (no pain)" was written at the beginning and "10 (most intense pain)" was written at the end and the patient was asked to mark the pain intensity they perceived at rest, active use and at night on the line. The pain intensity of the individual was recorded by measuring the distance marked on the line in millimeters. It has been reported that the Turkish version of the VAS is a valid and reliable measurement tool in the evaluation of musculoskeletal disorders

Sleep Quality Index

时间窗: From baseline to the end of the treatment at 8 weeks

It was examined with Pittsburgh Sleep Quality Index (PSQI). It is a 24-question scale developed by Buysse et al. in 1989 that evaluates sleep quality in the last month, and the last 5 questions are used only for clinical evaluation. The sum of the scores of 7 components including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use and daytime dysfunction gives the total score index. The total PDQI score ranges from 0 to 21; a score above 5 points indicates poor sleep quality; a score of 5 points or less indicates good sleep quality.

Stress level

时间窗: From baseline to the end of the treatment at 8 weeks

It was examined with Perceived Stress Scale.It was developed by Cohen, Kamarck and Mermelstein (1983) and consists of 14 items. The scale consists of two sub-dimensions: stress/discomfort perception and self-efficacy perception. Participants rate the stress they perceive in the scale as "0" never, "1" almost never, "2" sometimes, "3" often, and "4" very often. The stress level perceived by individuals is determined by summing the scores obtained from the items. A score between 0-56 points is obtained from the scale and the higher the score, the higher the perceived stress level.

Quality of Life

时间窗: From baseline to the end of the treatment at 8 weeks

It was examined with Short Form-36 (SF-36) Quality of Life Scale. SF-36 was developed by the Rand Corporation to obtain information about the health status of the individual. It consists of 8 sub-dimensions and 36 items. The sub-dimensions consist of physical function, social function, physical role difficulty, emotional state difficulty, mental health, energy/vitality, pain, and general perception of health. "0" represents the worst health status, while "100" represents the best health status. Each sub-dimension is evaluated individually without calculating the total score, and in our study, general health perception was evaluated.

次要结局

  • Presence and severity of Temporomandibular Joint Disorder (TMD) symptoms(From baseline to the end of the treatment at 8 weeks)
  • Bruxism(From baseline to the end of the treatment at 8 weeks)
  • Trigger Point(From baseline to the end of the treatment at 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Merve Berika Kadıoğlu

Lecturer

Ankara University

研究点 (2)

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